Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Urinary dysfunction
研究概览
简要总结
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.
Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.
详细描述
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.
The Aim of the study is to compare two surgical approaches (robotic versus laparoscopic) for rectal cancer treatment regarding functional outcomes (sexual and urinary dysfunctions), quality of life, post operative outcomes and oncologic outcomes.
Patients with the diagnosis of T3 mid and low rectal cancer will be randomized to robotic or laparoscopic procedure after neoadjuvant chemoradiation. Quality of life questionnaires and Urodynamic test will be applied before and after the surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mid or low Rectal Adenocarcinoma
- •Performance Status (ECOG) 0 - 2
排除标准
- •Metastatic disease
- •Congestive heart failure
- •Renal failure
- •Pregnancy
- •Neurologic disorders
- •Alfa blockers user
- •Patients who are candidates to APR ( Abdomino-perineal resection)
研究组 & 干预措施
Robotic
Robotic low anterior resection
干预措施: Robotic (Procedure)
Laparoscopic
Laparoscopic low anterior resection
干预措施: Laparoscopic (Procedure)
结局指标
主要结局
Urinary dysfunction
时间窗: Change from Before surgery to 3 months after surgery
Urodynamic test
次要结局
- Sexual dysfunction(Change from Before surgery to 3 months after surgery)
- Post operative outcomes(Within the first 30 days after the surgical procedure)
- Costs(From the surgical procedure until the last follow up, which will be 24 months or the day of death.)
研究者
Marcus Valadão
Principal Investigator
Instituto Nacional de Cancer, Brazil